- Email: [email protected]
Recent Advances in Developmental Pharmacokinetics in Children
Parallel pharmacogenetic approach by assessing the cost-consequences for the health care system. Still we are exploring new possible markers in the CRC pharmacogenomics by investigating the predictive/prognostic role of panels of polymorphisms in genes mediating the integration of the environment effect on drugs pharmacokinetics and pharmacodynamics. Specifically the pharmacological impact of genetic variants in miRNA related genes, in nuclear receptors genes, and in genes related to the patients immunological profile, have been investigated. The most recent results of these studies will be presented.
I will use empirical research into education for intravenous fluid therapy to argue that patient safety has driven uncertainty underground and this is potentially dangerous. Despite educationalists’ best efforts, graduates remain ill-prepared for practice. Being ever more rational by introducing more and more testing could, paradoxically, prepared graduates even worse. I will use the case of prescribing insulin to describe how my research team is trying to rehabilitate uncertainty within residency education and suggest how a medical curriculum could turn irrationality into a good.
Novel Treatment Options in Depression and Psychosis
A Call to Incorporate Systems-Theoretic Advances and Human Factors into Our Existing Investigations of Harm in Human Clinical Research Involving Healthcare Products
E. Ceskova1,2,3,4 Central European Institute of Technology (CEITEC), Masaryk University, Brno, Czech Republic; 2Department of Psychiatry, Faculty Hospital Brno, Czech Republic; 3Psychiatry, Faculty Hospital Ostrava, Czech Republic; and 4Department of Neurology and Psychiatry, Faculty of Medicine, University of Ostrava, Czech Republic Despite tremendous developments in central nervous system research, many current treatment options are suboptimal, especially in severe mental disorders. There are two main methods in medicine of improving health care: seeking new treatment procedures and optimizing the existing ones. Treatment optimization includes using practical tools, such as therapeutic drug monitoring, and implementing general trends into clinical practice. New pharmacological treatment options include more sophisticated forms of monoaminergic drugs, old new drugs rediscovered on the basis of better understanding the pathophysiology of mental illnesses, and drugs aimed at new treatment targets.
1
Recent Advances in Developmental Pharmacokinetics in Children S.N. de Wildt1,2 1 Radboud University, Nijmegen, The Netherlands; and 2Erasmus University Medical Center, Rotterdam, The Netherlands Growth and development largely impact drug disposition in children. The underlying processes, absorption, distribution, metabolism and excretion, are subject to major changes during childhood. In the last year, our understanding of these changes and how they affect pharmacokinetics has dramatically increased by the use of innovative study methods, including sensitive methods for ex vivo studies in human tissue, opportunistic PK studies, limited sample analysis methods, microdosing as well as modelling and simulation. In this presentation, these innovative methods will be presented, including how their use has expanded our knowledge on developmental pharmacokinetics. Finally, the translation of this knowledge to agespecific dosing guidelines and the implementation in real-life practice will be shown.
Preparing for Practice T. Dornan; R. McCrory; and R. Conn Queen’s University, Belfast, Northern Ireland, United Kingdom Flexner put medical education on a scientific footing a century ago, since when it has been characterised by scientific rationalism. Alongside science, medical education has more recently adopted pragmatic types of rationalism – evidence-based medicine and competency-based education. Educationally, this has shifted medicine towards a ‘pedagogy of certainty’, dominated by reliable testing of knowledge and skills. This begs the question: ‘Is medicine always so rational?’ Schön, a guru of reflective practice didn’t think so, and neither did Shulman, a leading US educationalist. He said other professions could learn from medicine’s ‘pedagogy of uncertainty’.
August 2017
B. Bégaud1; E. Daemen2; I. Dokas3; B.D. Edwards4; J.M. Fishbein5; H.E. Greenberg6,7; A. Hochberg8; H. Le Louet9; J. Lyngvig10; N. Mogles11; K. Owen12; C. Prendergast13; M. Rejzek14; D. Webb15; M. Whalen16; and S. Whiteley17 1 Département de Pharmacologie Médicale, Université de Bordeaux; 2TRIUM Clinical Consulting NV; 3Civil Engineering Department, Democritus University of Thrace, Xanthi, Greece; 4 NDA Regulatory Science Ltd and Alliance Clinical Research Excellence & Safety (Lead Author); 5Safety and Medical Affairs/ Commercialization Services at PRA Health Sciences; 6Janssen Research and Development, LLC, Titusville, New Jersey; 7 Pharmacology & Experimental Therapeutics, Thomas Jefferson University; 8BSE Scientific Enablement Leader, F. Hoffmann–La Roche Ltd; 9Fédération Assistance Publique Hôpitaux de Paris, President of Council for International Organizations of Medical Sciences; 10Past Senior Vice President and Managing Director Europe, Middle East and Africa, Drug Information Association Past Executive Director, Danish Medicines Agency; 11Department of Computer Science University of Bath; 12Managing Director of Owen Clinical Consulting Ltd; 13Marketed Product Safety Services, Quintiles IMS; 14Deputy Head of the Safety-Critical Systems Research Lab, Zurich University of Applied SciencesSofia Trantza, Department of Adverse Reactions, Division of Clinical Trials, National Medicines Agency; 15Clinical Pharmacology Unit, University of Edinburgh; 16Alliance for Clinical Research Excellence and Safety (ACRES); and 17Whiteley Aerospace Safety Engineering & Management Limited, United Kingdom Objectives: The participant will better understand novel and progressive solutions for investigating harm in clinical research and invited to join a project team about independent investigation into harm in clinical research. Purpose: We believe that repetition of potentially preventable and adverse outcomes during clinical research, through not identifying and acting upon all systematic vulnerabilities, is a situation that needs urgent change and that time for action is now. Methods: A joint assessment has been performed by individual pharmacology and pharmaceutical professionals acting in their own capacity including members of the Alliance for Clinical Research Excellence and Safety and the International Society of Pharmacovigilance. Results: By building on the extensive pharmacological and regulatory investigations that already take place, we are calling for a fuller and more robust systems-based approach to the independent investigation of clinical research when serious incidents of harm occur starting with first-into-human trials. To complement existing activities and regulations, we propose an additional approach blending evidence derived from pharmacological and organisational science which addresses human factors and transparency to enhance organisational learning and continuous improvement (1,2).
e103
I will use empirical research into education for intravenous fluid therapy to argue that patient safety has driven uncertainty underground and this is potentially dangerous. Despite educationalists’ best efforts, graduates remain ill-prepared for practice. Being ever more rational by introducing more and more testing could, paradoxically, prepared graduates even worse. I will use the case of prescribing insulin to describe how my research team is trying to rehabilitate uncertainty within residency education and suggest how a medical curriculum could turn irrationality into a good.
Novel Treatment Options in Depression and Psychosis
A Call to Incorporate Systems-Theoretic Advances and Human Factors into Our Existing Investigations of Harm in Human Clinical Research Involving Healthcare Products
E. Ceskova1,2,3,4 Central European Institute of Technology (CEITEC), Masaryk University, Brno, Czech Republic; 2Department of Psychiatry, Faculty Hospital Brno, Czech Republic; 3Psychiatry, Faculty Hospital Ostrava, Czech Republic; and 4Department of Neurology and Psychiatry, Faculty of Medicine, University of Ostrava, Czech Republic Despite tremendous developments in central nervous system research, many current treatment options are suboptimal, especially in severe mental disorders. There are two main methods in medicine of improving health care: seeking new treatment procedures and optimizing the existing ones. Treatment optimization includes using practical tools, such as therapeutic drug monitoring, and implementing general trends into clinical practice. New pharmacological treatment options include more sophisticated forms of monoaminergic drugs, old new drugs rediscovered on the basis of better understanding the pathophysiology of mental illnesses, and drugs aimed at new treatment targets.
1
Recent Advances in Developmental Pharmacokinetics in Children S.N. de Wildt1,2 1 Radboud University, Nijmegen, The Netherlands; and 2Erasmus University Medical Center, Rotterdam, The Netherlands Growth and development largely impact drug disposition in children. The underlying processes, absorption, distribution, metabolism and excretion, are subject to major changes during childhood. In the last year, our understanding of these changes and how they affect pharmacokinetics has dramatically increased by the use of innovative study methods, including sensitive methods for ex vivo studies in human tissue, opportunistic PK studies, limited sample analysis methods, microdosing as well as modelling and simulation. In this presentation, these innovative methods will be presented, including how their use has expanded our knowledge on developmental pharmacokinetics. Finally, the translation of this knowledge to agespecific dosing guidelines and the implementation in real-life practice will be shown.
Preparing for Practice T. Dornan; R. McCrory; and R. Conn Queen’s University, Belfast, Northern Ireland, United Kingdom Flexner put medical education on a scientific footing a century ago, since when it has been characterised by scientific rationalism. Alongside science, medical education has more recently adopted pragmatic types of rationalism – evidence-based medicine and competency-based education. Educationally, this has shifted medicine towards a ‘pedagogy of certainty’, dominated by reliable testing of knowledge and skills. This begs the question: ‘Is medicine always so rational?’ Schön, a guru of reflective practice didn’t think so, and neither did Shulman, a leading US educationalist. He said other professions could learn from medicine’s ‘pedagogy of uncertainty’.
August 2017
B. Bégaud1; E. Daemen2; I. Dokas3; B.D. Edwards4; J.M. Fishbein5; H.E. Greenberg6,7; A. Hochberg8; H. Le Louet9; J. Lyngvig10; N. Mogles11; K. Owen12; C. Prendergast13; M. Rejzek14; D. Webb15; M. Whalen16; and S. Whiteley17 1 Département de Pharmacologie Médicale, Université de Bordeaux; 2TRIUM Clinical Consulting NV; 3Civil Engineering Department, Democritus University of Thrace, Xanthi, Greece; 4 NDA Regulatory Science Ltd and Alliance Clinical Research Excellence & Safety (Lead Author); 5Safety and Medical Affairs/ Commercialization Services at PRA Health Sciences; 6Janssen Research and Development, LLC, Titusville, New Jersey; 7 Pharmacology & Experimental Therapeutics, Thomas Jefferson University; 8BSE Scientific Enablement Leader, F. Hoffmann–La Roche Ltd; 9Fédération Assistance Publique Hôpitaux de Paris, President of Council for International Organizations of Medical Sciences; 10Past Senior Vice President and Managing Director Europe, Middle East and Africa, Drug Information Association Past Executive Director, Danish Medicines Agency; 11Department of Computer Science University of Bath; 12Managing Director of Owen Clinical Consulting Ltd; 13Marketed Product Safety Services, Quintiles IMS; 14Deputy Head of the Safety-Critical Systems Research Lab, Zurich University of Applied SciencesSofia Trantza, Department of Adverse Reactions, Division of Clinical Trials, National Medicines Agency; 15Clinical Pharmacology Unit, University of Edinburgh; 16Alliance for Clinical Research Excellence and Safety (ACRES); and 17Whiteley Aerospace Safety Engineering & Management Limited, United Kingdom Objectives: The participant will better understand novel and progressive solutions for investigating harm in clinical research and invited to join a project team about independent investigation into harm in clinical research. Purpose: We believe that repetition of potentially preventable and adverse outcomes during clinical research, through not identifying and acting upon all systematic vulnerabilities, is a situation that needs urgent change and that time for action is now. Methods: A joint assessment has been performed by individual pharmacology and pharmaceutical professionals acting in their own capacity including members of the Alliance for Clinical Research Excellence and Safety and the International Society of Pharmacovigilance. Results: By building on the extensive pharmacological and regulatory investigations that already take place, we are calling for a fuller and more robust systems-based approach to the independent investigation of clinical research when serious incidents of harm occur starting with first-into-human trials. To complement existing activities and regulations, we propose an additional approach blending evidence derived from pharmacological and organisational science which addresses human factors and transparency to enhance organisational learning and continuous improvement (1,2).
e103